Medroxyprogesterone Acetate

Product NDC: 0548-5410
Requested package NDC: 0548-5410-00
11-digit product format: 005485410
Labeler code: 0548
Product ID: 0548-5410_24f666b3-e168-4860-87d3-bd6c02617ede
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Medroxyprogesterone acetate
Dosage form: INJECTION, SUSPENSION, EXTENDED RELEASE
Route: INTRAMUSCULAR
Labeler: Amphastar Pharmaceuticals, Inc.
Application: ANDA077235
Marketing category: ANDA
Marketing start: 2017-11-28
Substance: MEDROXYPROGESTERONE ACETATE
Active strength: 150 mg/mL
Pharmacologic classes: Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0548-5410	0548-5410-00	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077235-001	MEDROXYPROGESTERONE ACETATE	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB		2017-11-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077235-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077235-001	MEDROXYPROGESTERONE ACETATE	150MG/ML	INJECTABLE / INJECTION	AB	2017-11-28	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A077235-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077235-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077235-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077235-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077235-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077235-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077235-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077235-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077235-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077235-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077235-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077235-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077235-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077235-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077235-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077235-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077235-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077235-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077235-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077235-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077235-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077235-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077235-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077235-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077235-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077235-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077235-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077235-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077235-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077235-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077235-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077235-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077235-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077235-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077235-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077235-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077235-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077235-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077235-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077235-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b8fdf1ba-dff9-e1f2-2551-c9b63aaa8dce	Product name	6	20240606
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
882e78d5-69f7-4a43-812f-1c1628241bbc	Product name	1	20150910
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
034a0bf8-c98c-0b66-1310-f87bb3a2f8a2	Product name	1	20140508
51a98800-9a04-9e42-2219-e588f17f9e48	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
f363ed61-d8ad-8f59-ee92-52a12578e008	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0548-5410-00	ML - Milliliter	0548-5410	2850e212-6f29-492e-a351-8f9d7b2aaead	1	2019-10-07
0548-5410-25	ML - Milliliter	0548-5410	e524f947-7a68-4509-8994-c1ed25229629	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0548-5410	MEDROXYPROGESTERONE ACETATE INJECTION, SUSPENSION, EXTENDED RELEASE [AMPHASTAR PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC	20221221_e364a31e-8926-4bda-b00e-efb097bd3830.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Medroxyprogesterone Acetate	MEDROXYPROGESTERONE ACETATE	Amphastar Pharmaceuticals, Inc.	fda1aa8a-5739-482a-b4f6-9741ef4d9977	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077235 application number: ANDA077235

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
C2QI4IOI2G	MEDROXYPROGESTERONE ACETATE	71-58-9	MEDROXYPROGESTERONE ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1000126	medroxyPROGESTERone acetate 150 MG in 1 ML Injection	PSN	e364a31e-8926-4bda-b00e-efb097bd3830	2
1000153	medroxyPROGESTERone acetate 150 MG in 1 ML Prefilled Syringe	PSN	e364a31e-8926-4bda-b00e-efb097bd3830	2
1000126	1 ML medroxyprogesterone acetate 150 MG/ML Injection	SCD	e364a31e-8926-4bda-b00e-efb097bd3830	2
1000153	1 ML medroxyprogesterone acetate 150 MG/ML Prefilled Syringe	SCD	e364a31e-8926-4bda-b00e-efb097bd3830	2
1000126	medroxyprogesterone acetate 150 MG per 1 ML Injection	SY	e364a31e-8926-4bda-b00e-efb097bd3830	2
1000153	medroxyprogesterone acetate 150 MG per 1 ML Prefilled Syringe	SY	e364a31e-8926-4bda-b00e-efb097bd3830	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0548-5410-00	00548541000	1 VIAL, SINGLE-DOSE in 1 CARTON (0548-5410-00) / 1 mL in 1 VIAL, SINGLE-DOSE	2019-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Medroxyprogesterone Acetate	Amphastar Pharmaceuticals, Inc.	2022-12-20	HUMAN PRESCRIPTION DRUG LABEL	2